| Device Classification Name |
Permanent Pacemaker Electrode
|
|---|
| 510(k) Number |
K991169 |
|---|
| Device Name |
SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854 |
|---|
| Applicant |
| Biotronik, Inc. |
| 6024 Jean Rd. |
|
Lake Oswego,
OR
97035
|
|
| Applicant Contact |
Jon Brumbaugh |
| Correspondent |
| Biotronik, Inc. |
| 6024 Jean Rd. |
|
Lake Oswego,
OR
97035
|
|
| Correspondent Contact |
Jon Brumbaugh |
| Regulation Number | 870.3680 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 04/07/1999 |
|---|
| Decision Date | 07/01/1999 |
|---|
| Decision |
SE SUBJECT TO TRACKING REG
(ST) |
|---|
| Regulation Medical Specialty |
Cardiovascular
|
|---|
| 510k Review Panel |
Cardiovascular
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|